Final Up to date on November 4, 2022 by GlobeNewsWire
NDA Submission for Nyxol for RM and Initiation of VEGA-2 on Observe for This fall 2022
Topline Knowledge from ZETA-1 Part 2b Trial of Oral APX3330 Anticipated in Early 2023
FARMINGTON HILLS, Mich., Nov. 04, 2022 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical firm centered on creating and commercializing therapies for the remedy of refractive and retinal eye problems, pronounces monetary outcomes for the third quarter ended September 30, 2022 and supplies a company replace.
“Through the third quarter, Ocuphire continued to execute components of our strategic plan to deliver modern remedies to sufferers with extremely prevalent refractive and diabetic retinal ailments,” mentioned Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. “With enrollment and 24-week remedy accomplished in over 100 sufferers in our ZETA-1 Part 2b trial of APX3330, we look ahead to sharing topline ends in early 2023, bringing us nearer to delivering a possible oral choice for diabetic retinopathy sufferers. We’re on observe for NDA submission for Nyxol for reversal of mydriasis within the fourth quarter 2022. We have now sturdy momentum and are poised to ship on a number of catalysts going ahead that we imagine will create important worth for our firm and shareholders.”
Key Anticipated Future Milestones
Reversal of Mydriasis (RM): Plan to submit New Drug Software (NDA) with the FDA for Nyxol in RM indication in This fall 2022, with potential approval and industrial launch as first dilation reversal drop in 2023.Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Plan to report top-line outcomes from the ZETA-1 Part 2b trial of APX3330 in early 2023. APX3330 is a novel oral remedy with a twin mechanism of motion in validated pathways, reducing each irregular angiogenesis and irritation. Presbyopia: Plan to provoke VEGA-2 Part 3 trial in This fall 2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive remedy. As well as, VEGA-3 (2nd Part 3) and LYRA-1 (1-year security) trials are deliberate to start in 2023.
Third Quarter and Latest Enterprise Highlights
Medical and Regulatory Improvement
In September, the Firm introduced that the final of the 103 enrolled sufferers within the ZETA-1 Part 2b trial of oral APX3330 for the remedy of diabetic retinopathy (DR) accomplished the ultimate go to of the 24-week research.In September, the Firm introduced that U.S. Meals and Drug Administration (FDA) has granted a small-business waiver of the Prescription Drug Consumer Payment Act (PDUFA) charge of $3.1 million for the 505(b)(2) NDA for Nyxol.
Shows, Publications, and Conferences
12 months so far, Ocuphire was represented at a number of key ophthalmological conferences with updates on Nyxol in RM, presbyopia and night time imaginative and prescient disturbances, in addition to masked security knowledge for APX3330 in DR. In complete, greater than 25 papers, posters, and panel talks had been introduced over 20 medical and trade conferences. Highlights in October and early November 2022: Mitchell Jackson, MD introduced a poster highlighting presbyopia knowledge on the American Academy of Ophthalmology Annual Assembly in Chicago, IL.Distinguished optometry thought leaders and medical trial investigators Justin Schweitzer, OD, Mitch Ibach, OD, Leslie O’Dell, OD, Shane Foster, OD, Doug , Devries, OD and Shane Kannarr, OD introduced six posters on Nyxol and APX3330 on the American Academy of Optometry Annual Assembly in San Diego, CA.The Firm introduced publication of an earlier Part 2 medical trial in sufferers with extreme night time imaginative and prescient disturbances within the BMC Ophthalmology peer-reviewed journal. The publication could be accessed right here.In October, the Firm held a Key Opinion Chief (KOL) webinar on oral APX3330. The occasion featured displays by KOLs Peter Kaiser, MD, from the Cleveland Clinic, Caroline Baumal, MD, from Tufts Medical Middle, and David Lally, MD, from New England Retina Consultants. KOL. The dialogue highlighted the unmet want and present remedy panorama for DR/DME and included new knowledge on research demographics and 24-week masked security knowledge from the ZETA-1 trial. A replay of the occasion could be discovered on the corporate’s company web site right here.
Company
On August 2, 2022, Ocuphire was granted prolonged mental property safety for Nyxol with the issuance of U.S. Patent No. 11,400,077 with claims directed to strategies for mydriasis remedy utilizing phentolamine, prolonged by 5 years into 2039.In September, the Firm appointed seven new Key Opinion Leaders (KOLs) throughout retina, cornea/refractive, and medical optometry to its Medical Advisory Board (MAB): Anat Loewenstein, MD, PhD, Caroline Baumal, MD, Zaina Al-Mohtaseb, MD, Inder Paul Singh, MD, Leslie O’Dell, OD, Selina McGee, OD, Justin Schweitzer, OD.
Third Quarter Ended September 30, 2022, Monetary Highlights
As of September 30, 2022, Ocuphire had money and money equivalents of roughly $13.9 million. Primarily based on present projections, administration believes the present money available will probably be enough to fund operations into the fourth quarter of 2023. Web money utilized in working actions within the third quarter of 2022 was $4.5 million, with a cumulative complete for the 9 months ended September 30, 2022, of $14.5 million.
Common and administrative bills for the three and 9 months ended September 30, 2022, had been $1.7 million and $5.2 million, respectively, in comparison with $1.6 million and $6.7 million, respectively, for the three and 9 months ended September 30, 2021. The rise from the comparable quarter in 2021 was largely attributed to a rise in authorized prices on a internet foundation. The lower from the comparable 9 months in 2021 was largely attributed to a non-cash settlement with sure traders within the comparable prior 12 months interval, offset by a slight enhance generally and administrative bills attributed to larger payroll and different working prices within the present 12 months interval when in comparison with the comparable prior 12 months interval.
Analysis and improvement bills for the three and 9 months ended September 30, 2022, had been $2.8 million and $10.8 million, respectively, in comparison with $3.1 million and $10.4 million, respectively, for the three and 9 months ended September 30, 2021. The lower from the comparable quarter in 2021 was primarily attributable to the completion of medical trials and the timing of producing actions for Nyxol and APX3330. The rise from the comparable 9 months in 2021 was primarily attributable to the timing of medical trials and manufacturing actions for Nyxol and APX3330 in addition to regulatory, preclinical and different improvement actions.
The overall loss from operations for the three and 9 months ended September 30, 2022, was $4.5 million and $16.0 million, respectively, in comparison with $4.2 million and $16.6 million, respectively, for the three and 9 months ended September 30, 2021.
Web loss for the three and 9 months ended September 30, 2022, was $4.5 million and $16.1 million, respectively, in comparison with $4.2 million and $50.4 million, respectively, for the three and 9 months ended September 30, 2021. Web loss per share for the three and 9 months ended September 30, 2022, was ($0.22) and ($0.82) per share, respectively, in comparison with ($0.25) and ($3.64) per share, respectively, for the comparable intervals in 2021.
For additional particulars on Ocuphire’s monetary outcomes, check with the Firm’s Quarterly Report on Kind 10-Q for the quarter ended September 30, 2022, to be filed with the Securities and Alternate Fee.
About Ocuphire Pharma
Ocuphire is a publicly traded (Nasdaq: OCUP), clinical-stage, ophthalmic biopharmaceutical firm centered on creating and commercializing small-molecule therapies for the remedy of refractive and retinal eye problems.
The Firm’s lead product candidate, Nyxol(R) eye drops (0.75% phentolamine ophthalmic answer), is a once-daily, preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to scale back pupil measurement and is being developed for 3 indications, together with reversal of pharmacologically induced mydriasis (RM), presbyopia and dim gentle or night time imaginative and prescient disturbances (NVD). Nyxol has been studied in 12 accomplished medical trials, together with lately reported constructive knowledge from the next trials:
MIRA-2 (NCT04620213), MIRA-3 (NCT05134974), and MIRA-4 (NCT05223478 pediatric security trial) registration trials for the remedy of RMVEGA-1 (NCT04675151) Part 2 trial of Nyxol for remedy of presbyopia, which evaluated each Nyxol as a single agent and Nyxol with low dose pilocarpine (“LDP”) 0.4% as adjunctive therapyLYNX-1 (NCT04638660) Part 3 trial of Nyxol for night time imaginative and prescient disturbances (NVD)
Ocuphire’s second product candidate, APX3330, is an oral pill designed to inhibit angiogenesis and irritation pathways related to retinal and choroidal vascular ailments, comparable to diabetic retinopathy (DR) and diabetic macular edema (DME). APX3330 has been studied in 11 Part 1 and a pair of trials. The Firm introduced the completion of final affected person final go to in late August in ZETA-1 (NCT04692688).
For extra data, go to www.ocuphire.com.
Ahead Trying Statements
Statements contained on this press launch relating to issues that aren’t historic information are “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Such statements embody, however aren’t restricted to, statements regarding medical and regulatory milestones for Ocuphire’s indications, together with Ocuphire’s potential NDA submission, initiation of sure trials, and receipt of topline knowledge, Ocuphire’s enterprise technique and potential progress, and commercialization of Ocuphire’s product candidates. These forward-looking statements are based mostly upon Ocuphire’s present expectations and contain assumptions which will by no means materialize or could show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of varied dangers and uncertainties, together with, with out limitation: (I) the success and timing of regulatory submissions and pre-clinical and medical trials, together with enrollment and knowledge readouts; (ii) regulatory necessities or developments; (iii) modifications to medical trial designs and regulatory pathways; (iv) modifications in capital useful resource necessities; (v) dangers associated to the shortcoming of Ocuphire to acquire enough extra capital to proceed to advance its product candidates and its preclinical applications; (vi) legislative, regulatory, political and financial developments, (vii) modifications in market alternatives, (viii) the consequences of COVID-19 on medical applications and enterprise operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the upkeep of Ocuphire’s mental property rights. The foregoing overview of essential components that would trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and ought to be learn together with statements which might be included herein and elsewhere, together with the chance components detailed in paperwork which have been and could also be filed by Ocuphire every now and then with the SEC. All forward-looking statements contained on this press launch communicate solely as of the date on which they had been made. Ocuphire undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made.
Contacts
CorporateInvestor RelationsMina Sooch, MBACEO & Founderir@ocuphire.comCorey Davis, Ph.D.LifeSci Advisorscdavis@lifesciadvisors.comBret ShapiroCoreIRbrets@coreir.com Ocuphire Pharma, Inc.Condensed Stability Sheets(in 1000’s, besides share quantities and par worth) As of September 30, December 31, 2022 2021 (unaudited) Property Present property: Money and money equivalents$13,855 $24,534 Prepaids and different present property 605 1,314 Brief-term investments 101 219 Complete present property 14,561 26,067 Property and tools, internet 7 10 Complete property$14,568 $26,077 Liabilities and stockholders’ fairness Present liabilities: Accounts payable$1,468 $1,584 Accrued bills 1,223 1,733 Brief-term mortgage — 538 Complete present liabilities 2,691 3,855 Warrant liabilities — — Complete liabilities 2,691 3,855 Commitments and contingencies Stockholders’ fairness: Most popular inventory, par worth $0.0001; 10,000,000 shares approved as of September 30, 2022, and December 31, 2021; no shares issued and excellent at September 30, 2022 and December 31, 2021. — — Widespread inventory, par worth $0.0001; 75,000,000 shares approved as of September 30, 2022 and December 31, 2021; 20,801,506 and 18,845,828 shares issued and excellent at September 30, 2022 and December 31, 2021, respectively. 2 2 Extra paid-in-capital 117,296 111,588 Amassed deficit (105,421) (89,368)Complete stockholders’ fairness 11,877 22,222 Complete liabilities and stockholders’ fairness$14,568 $26,077 Ocuphire Pharma, Inc.Condensed Consolidated Statements of Complete Loss(in 1000’s, besides share and per share quantities)(Unaudited) For the Three Months Ended For the 9 Months Ended September 30, September 30, 2022 2021 2022 2021Collaborations income $— $489 $– $589 Working bills: Common and administrative 1,703 1,595 5,215 6,707 Analysis and improvement 2,835 3,126 10,769 10,437 Complete working bills 4,538 4,721 15,984 17,144 Loss from operations (4,538) (4,232) (15,984) (16,555)Curiosity expense — — (9) — Truthful worth change of warrant liabilities — — — (33,829)Different earnings (expense), internet 7 2 (60) 4 Loss earlier than earnings taxes (4,531) (4,230) (16,053) (50,380)Profit (provision) for earnings taxes — — — — Web loss (4,531) (4,230) (16,053) (50,380)Different complete loss, internet of tax — — — — Complete loss $(4,531) $(4,230) $(16,053) $(50,380)Web loss per share: Fundamental and diluted $(0.22) $(0.25) $(0.82) $(3.64)Variety of shares utilized in per share calculations: Fundamental and diluted 20,498,229 16,925,006 19,635,651 13,841,067
